Sr Director, QMS

Sr. Director, Quality Management Systems Dexcom is seeking a strategic leader to oversee a global Quality Management System (QMS) that meets FDA, ISO 13485, MDR, and other international regulatory requirements while supporting business growth and innovation. Responsibilities Own and evolve the global QMS strategy, aligning with corporate objectives and regulatory expectations. Lead the design, implementation, and continuous improvement of key QMS processes, including document control, CAPA, metrics and analytics, partnership management, and audit management. Own the corporate CAPA program, ensuring world‑class execution and performance. Drive harmonization and standardization of quality processes across global sites and regions. Establish a Quality Intelligence program focused on risks and developments across the medical device industry. Own project management for the Quality organization, focusing on continuous improvement opportunities. Ensure inspection readiness at all times and assist with enterprise‑level responses to regulatory inspections and audits. Partner closely with Regulatory Affairs to interpret evolving global regulations and proactively integrate requirements into the QMS. Build, develop, and lead a high‑performing, global QMS team. Champion a culture of quality, compliance, and continuous improvement across the organization. Leverage digital tools and data analytics to modernize and scale the QMS, improving efficiency and visibility. Provide executive‑level reporting on QMS performance, risks, and improvement initiatives. Qualifications & Skills Strategic, forward‑thinking quality leader who balances compliance with agility in a fast‑paced, innovation‑driven environment. Proven ability to lead and scale global teams, driving alignment across functions and geographies. Strong executive presence with the ability to influence senior leadership and cross‑functional stakeholders. Deep knowledge of global QMS requirements, including FDA 21 CFR Part 820, ISO 13485, EU MDR, and other international standards. Experience leading regulatory inspections and audits with positive outcomes. Track record of building or transforming QMS frameworks in a complex, global organization. Operational excellence: implementing scalable, efficient quality processes that support rapid business growth. Strong systems mindset with experience driving digital transformation within QMS platforms (e.g., eQMS systems). Data‑driven decision‑maker who uses metrics to drive continuous improvement. Strategic mindset, anticipating regulatory trends and corporate needs, and proactively adapting systems and processes. Strong business acumen with an understanding of how Quality enables innovation and market success. Excellent cross‑functional collaboration and communication skills, translating complex regulatory requirements into practical, business‑friendly solutions. Clear and compelling communicator capable of engaging audiences from frontline teams to executive leadership. What You’ll Get Front‑row seat to life‑changing continuous glucose monitoring technology. Opportunity to learn about the Dexcom Warriors community. Full and comprehensive benefits program. Global growth opportunities. Access to career‑development programs and qualified tuition reimbursement. Work in an exciting, innovative, industry‑leading organization committed to employees, customers, and communities. Additional Details Travel required: 15–25%. Salary: $209,600.00 – $349,300.00. Typical requirements – Bachelor’s degree, 17+ years of industry experience, 13+ years of successful leadership experience. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr 1 DexCom Inc